Back to resultsA Study of Diabetic Patients With De Novo Native Coronary Artery Lesions (SCORPIUS)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
CYPHER sirolimus-eluting stent
uncoated Bx VELOCITY balloon-expandable stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
- Manifest diabetes mellitus, proven by fasting glucose (12 h) > 127 mg/dl or oral glucose challenge: >= 200 mg/dl after 2 h or diabetes mellitus already treated with oral antidiabetics or insulin;
- Treatment of a de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with 2- or more-vessel-disease can be enrolled if previous treatment(s) of those lesions other than the target lesion have taken place at least 3 months prior to the enrolment to this study. If more than 1 study stent is necessary to treat the lesion, overlapping is strongly recommended;
- Target vessel diameter at the lesion site is >= 2.5mm and <= 3.5mm (visual estimate); (stents will be available in 2.5 / 3.0 mm width);
- Target lesion is <= 42mm in length (visual estimate); (stents will be available in 8, 18 and 33 mm length);
- Target lesion diameter stenosis is > 50% and <100% (visual estimate);
Exclusion Criteria:
None
Sites / Locations
- University of Essen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
CYPHER sirolimus-eluting stent
uncoated Bx VELOCITY balloon-expandable stent
Outcomes
Primary Outcome Measures
angiographic in-segment late loss
Secondary Outcome Measures
late loss
angiographic binary restenosis
target lesion revascularization (TLR)
target vessel revascularization (TVR)
target vessel failure (TVF)
procedure success
lesion success rate
resource use
productivity loss
Major Adverse Cardiac Events (MACE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00495898
Brief Title
A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions
Acronym
SCORPIUS
Official Title
A German Multicenter, Randomized, Controlled, Open-Label Study of the Cypher Sirolimus-Eluting Stent in the Treatment of Diabetic Patients With De Novo Native Coronary Artery Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent Delivery System.
Detailed Description
This is a multicenter (19 sites), prospective, 2 arm randomized study designed to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Patients with de novo native coronary artery lesions <= 42 mm in length and >=2.5mm and <=3.5mm in diameter (by visual estimate) will be included in the study. A total of 190 patients will be entered and randomly allocated to the CYPHERTM sirolimus-eluting stent or the uncoated Bx VELOCITY balloon-expandable stent at a 1:1 ratio. Patients will be followed for 12 months post-procedure, with all patients having a repeat angiography at 8 months (± 1 month).
It is anticipated the total duration of the study will be 18 months: 6 months to complete patient enrollment and 12 months for follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CYPHER sirolimus-eluting stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
uncoated Bx VELOCITY balloon-expandable stent
Intervention Type
Device
Intervention Name(s)
CYPHER sirolimus-eluting stent
Intervention Description
drug-eluting stent
Intervention Type
Device
Intervention Name(s)
uncoated Bx VELOCITY balloon-expandable stent
Intervention Description
bare metal stent
Primary Outcome Measure Information:
Title
angiographic in-segment late loss
Time Frame
8 months post-procedure
Secondary Outcome Measure Information:
Title
late loss
Time Frame
8 months post-procedure
Title
angiographic binary restenosis
Time Frame
8 months post-procedure
Title
target lesion revascularization (TLR)
Time Frame
8 months post-procedure
Title
target vessel revascularization (TVR)
Time Frame
8 months post-procedure
Title
target vessel failure (TVF)
Time Frame
8 months post-procedure
Title
procedure success
Time Frame
8 months post-procedure
Title
lesion success rate
Time Frame
0
Title
resource use
Time Frame
1 year post-procedure
Title
productivity loss
Time Frame
1 year post-procedure
Title
Major Adverse Cardiac Events (MACE)
Time Frame
30 days, and 8 and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
Manifest diabetes mellitus, proven by fasting glucose (12 h) > 127 mg/dl or oral glucose challenge: >= 200 mg/dl after 2 h or diabetes mellitus already treated with oral antidiabetics or insulin;
Treatment of a de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with 2- or more-vessel-disease can be enrolled if previous treatment(s) of those lesions other than the target lesion have taken place at least 3 months prior to the enrolment to this study. If more than 1 study stent is necessary to treat the lesion, overlapping is strongly recommended;
Target vessel diameter at the lesion site is >= 2.5mm and <= 3.5mm (visual estimate); (stents will be available in 2.5 / 3.0 mm width);
Target lesion is <= 42mm in length (visual estimate); (stents will be available in 8, 18 and 33 mm length);
Target lesion diameter stenosis is > 50% and <100% (visual estimate);
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dietrich Baumgart, MD, PhD
Organizational Affiliation
Universität Duisburg-Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17950142
Citation
Baumgart D, Klauss V, Baer F, Hartmann F, Drexler H, Motz W, Klues H, Hofmann S, Volker W, Pfannebecker T, Stoll HP, Nickenig G; SCORPIUS Study Investigators. One-year results of the SCORPIUS study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients. J Am Coll Cardiol. 2007 Oct 23;50(17):1627-34. doi: 10.1016/j.jacc.2007.07.035.
Results Reference
result
PubMed Identifier
22424016
Citation
Sinning JM, Baumgart D, Werner N, Klauss V, Baer FM, Hartmann F, Drexler H, Motz W, Klues H, Voelker W, Pfannebecker T, Stoll HP, Nickenig G; SCORPIUS Study. Five-year results of the Multicenter Randomized Controlled Open-Label Study of the CYPHER Sirolimus-Eluting Stent in the Treatment of Diabetic Patients with De Novo Native Coronary Artery Lesions (SCORPIUS) study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients. Am Heart J. 2012 Mar;163(3):446-53, 453.e1. doi: 10.1016/j.ahj.2011.12.010.
Results Reference
derived
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A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions
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